Country Quality Manager - Consumer Healthcare (CHC), Reading
Client: Sanofi
Location: Reading, United Kingdom
Job Category: -
EU work permit required: Yes
Job Reference: 0871867ba39c
Job Views: 10
Posted: 26.04.2025
Expiry Date: 10.06.2025
Job Description:
Requisition: CHC Country Quality Manager
Location: Reading, UK
Reports to: Country Quality Head & Responsible Person UK CHC
Mission and Key Responsibilities:
The CHC Country Quality Manager manages the implementation and maintenance of the CHC UK Affiliate Quality System, ensuring compliance with GxP regulatory requirements, CHC Global Quality standards, and UK legislation.
This role includes acting as back-up Good Distribution Practice Responsible Person and Responsible Person for Import according to Business Contingency Plans.
Key responsibilities include:
* Design, implement, and improve Quality Processes and ensure their respective implementation in the electronic Document Management System.
* Develop, roll-out training activities and oversee training effectiveness.
* Contribute to the selection and qualification of suppliers and subcontractors.
* Support in the identification and mitigation of Quality risks and define action plans in areas such as Quality Events, change management, audits, and (self-)inspections.
* Ensure Product Quality is maintained through the management of in-market Product Quality Complaints and the effective management of Quality incidents.
* Contribute to continuous improvement efforts through data analysis and trending.
* Manage activities related to the Falsified Medicine Directive.
* Support Responsible Person import activities.
Scope and Role Impact:
* Cross-functional management within the CHC UK Affiliate.
* Key role in ensuring consistent application of Quality requirements.
Required Skills and Experience:
* Educational Qualifications: Candidates must possess a diploma, certificate, or other evidence of formal qualifications awarded upon completion of a university or higher education course in pharmacy, chemistry, medicine, biology, or a related life science.
* Experience: Proven experience in the Good Distribution Practices (GDP) domain within an affiliate setting, demonstrating understanding of specific challenges and requirements.
* Knowledge: Understanding of GxP, quality risk analysis and management, regulatory requirements. Familiarity with EU Good Distribution Practices and UK Rules and Guidance for Pharmaceutical Distributors 2022.
* Languages: Proficiency in English
* Technical/Professional: Experience in Quality Systems, Continuous Improvement, and Life-cycle Management.
* For the RP-I role, full membership in a professional body with a published code of conduct is required. Acceptable bodies include: Royal Society of Biology, Royal Pharmaceutical Society, Royal Society of Chemistry.
* Soft Skills: Excellent communication skills, good organization, planning, priority setting, initiative, ability to work in a high-paced and changing environment, customer focus, hands-on experience with MS Excel, and experience with electronic platforms like Veeva Vault is a plus.
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